Triadic Interactions of Families With Autism and Oxytocin

What Was Tested

The trial (phase 1) is built around Oxytocin.

The study will investigate the effects of an intranasal administration of oxytocin (OT) to parents of children with autism spectrum disorders (ASD) on the quality of mother-father-child interactions.

Physiological and behavioral measures of parent-child triadic interaction quality will be assessed.

It had two arms (groups): Oxytocin Nasal Spray (experimental) and Placebo nasal spray (placebo comparator).

40 IUs of Oxytocin nasal spray will be administered to both parents at one time during the lab visit.

40 IUs of Placebo nasal spray will be administered to both parents at one time during the lab visit.

The registry classes the interventions as drug.

More on the Plan

While there has been progress into understanding the neurobiology and neuropsychology of schizophrenia and autism spectrum disorder, treatment options remain inadequate.

The researchers will test these hypotheses by exploring the effects of exogenously administered OT to caregivers on parent-child interactions and physiology during a laboratory-based parent-child interaction task.

Participants will be 40 triads consisting of mother, father, and child with ASD and 40 triads of mother, father, and typically developing (TD) children.

Families will come to their lab at UCSF's Parnassus campus for one 2-hour visit.

Who Took Part

It was open to people of any sex aged from 7 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age between 25 and 60 years old. Live with child. Read and communicate in English. Age between 7 and 12 years old. Lives with parents.

The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: female parents who state they are pregnant or have a positive pregnancy test; severe psychiatric, neurologic or medical illness; severe nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2013-08 with completion listed for 2015-05.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Parental social behavior (time frame: 37 minutes into lab visit).

It also tracked 2 secondary outcomes, for example Child and Parent Physiological Synchrony and Child social behavior.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.